Anterior Cruciate Ligament ReconstructionNCT05968729
Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol
A study testing Active Comparator: 0.25 m/s asymmetric session first and Active Comparator: 0.50 m/s asymmetric session first in people with Anterior Cruciate Ligament Reconstruction, run by University of Connecticut at 1 site in United States.
Trial summary
The purpose of this work is to conduct a comparative research-focused study to evaluate the effectiveness of how purposefully induced asymmetric walking protocols restore healthy, symmetric limb loading in individuals following post-anterior cruciate ligament reconstruction (ACLR) surgery. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Active Comparator: 0.25 m/s asymmetric session first and Active Comparator: 0.50 m/s asymmetric session first
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to read and speak English
- Age 18 - 30 years old
- Undergone ACLR surgery at the UConn Musculoskeletal Institute
- Must not have any concomitant surgeries or injuries
- Must be cleared to return-to-sport by a physician after they have completed rehabilitation
- Must be within 1 month of having been cleared for return-to-sport
- Must present with between-limb gait differences in load rate greater than 10%
Who cannot join
- Participants who have any recent inflammation, bleeding disorders, active bleeding, or infection within the lower limbs.
- History of injuries to their patellar tendon
- Cannot walk for extended periods of time
- Cannot have had any back and/or lower extremity injury that affects their ability to move.
- Cannot have difficulty or pain with walking, raising your arms, jogging, or jumping
- Must not be allergic to tape.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Connecticut
Storrs, Connecticut, 06269
Kristin Morgan, PhD, 860-486-8118, kristin.2.morgan@uconn.edu
About this study
The purpose of this work is to conduct a comparative research-focused study to evaluate the effectiveness of how purposefully induced asymmetric walking protocols restore healthy, symmetric limb loading in individuals following post-anterior cruciate ligament reconstruction (ACLR) surgery. Additionally, computational modeling and machine learning to model knee loading in the clinic to determine the optimal asymmetric walking protocol to restore healthy gait in post-ACLR individuals.
Read the detailed description
This is an intervention study in which participants will be randomized as to the order in which each of the two sessions are completed. Forty post-ACLR will who present with between-limb gait differences will perform two asymmetric walking sessions where they will walk with between-limb gait speed differences of 0.25 m/s and 0.50 m/s at three 15-minute intervals to evaluate the restoration of healthy gait. Post-ACLR participants will perform an asymmetric walking intervention protocol session on two different days. On one day they will perform the protocol with a 0.25 m/s between-limb difference and on a separate day they will perform the protocol with a 0.50 m/s between limb difference. For the 0.25 m/s condition, one limb will be set to 1.0 m/s and the other 1.25 m/s (i.e., 1.0 m/s - 1.25 m/s). Similarly, for the 0.50 m/s condition, one limb will be set to 1.0 m/s and the other 1.50 m/s (i.e., 1.0 m/s - 1.50 m/s). Each participant will perform both the 0.25 m/s and 0.50 m/s protocols on separate days, and we will randomize who performs which protocol first or second. At least 3 weeks must pass between the two one-day sessions. Patient-specific simulations will be generated in OpenSim for each of the 40 post-ACLR individuals to assess differences in knee joint loading. Together with machine learning, these models will help evaluate the effectiveness of the asymmetric walking protocol in reducing detrimental knee loading. The study team hypothesizes that the 0.50 m/s perturbation will produce a larger reduction in between-limb asymmetry than the 0.25 m/s perturbation and reduce detrimental knee loading.
- Being tested
- Active Comparator: 0.25 m/s asymmetric session first, Active Comparator: 0.50 m/s asymmetric session first
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: 0.25 m/s asymmetric session firstOther
Participants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s.
Active Comparator: 0.50 m/s asymmetric session firstOther
Participants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s.
| Study group | Role | What they receive |
|---|---|---|
| 0.25 m/s asymmetric session first | Active comparator | Participants will perform three 15-minute sessions of walking with a 0.25 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.25 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s. Receives: Other: Active Comparator: 0.25 m/s asymmetric session first |
| 0.50 m/s asymmetric walking session first | Active comparator | Participants will perform three 15-minute sessions of walking with a 0.50 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.5 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s. Receives: Other: Active Comparator: 0.50 m/s asymmetric session first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Loading Rate
The rate at which the force is generated (Body Weight/sec). A decrease in loading rate would suggest that the participants adopted improved motor control while an increase would reflect impaired of motor control.
Measured: Screening, Baseline, and Post-Treatment (immediately following the completion of the second session)
Change in Peak Vertical Ground Reaction Force
The largest force (newtons) produced during stance. An increase in force would that the participants are not properly engaging their muscles to control their movement.
Measured: Baseline, Post-Treatment (immediately following the completion of the second session)
Change in Stride Time
The time (seconds) measure from initial contact on the foot to the next initial contact on the same foot. A reduction in stride time would indicate that the participants are walking faster and more comfortable applying force to their limb during walking. An increase in walking speed, suggests that the participants are uncomfortable applying force to their limb.
Measured: Baseline, Post-Treatment (immediately following the completion of the second session)
Change in Knee Loading
The forces (newtons) experienced at the knee. An increase in knee loading would indicate that they participants are unable to properly support their knee during walking, while a reduction in knee loads would indicate the participants are engaging the appropriate muscles to support their knee during walking.
Measured: Baseline, Post-Treatment (immediately following the completion of the second session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Sep 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Kristin Morgan, University of Connecticut
- Investigators
- Kristin Morgan, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968729
- Sponsor's protocol ID
- H21-0176
- Other IDs
- K01AR079043
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol
- ClinicalTrials.gov ID
- NCT05968729
- Acronym / sponsor ID
- H21-0176
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this work is to conduct a comparative research-focused study to evaluate the effectiveness of how purposefully induced asymmetric walking protocols restore healthy, symmetric limb loading in individuals following post-anterior cruciate ligament reconstruction (ACLR) surgery. Additionally, computational modeling and machine learning to model knee loading in the clinic to determine the optimal asymmetric walking protocol to restore healthy gait in post-ACLR individuals.
Detailed description
This is an intervention study in which participants will be randomized as to the order in which each of the two sessions are completed. Forty post-ACLR will who present with between-limb gait differences will perform two asymmetric walking sessions where they will walk with between-limb gait speed differences of 0.25 m/s and 0.50 m/s at three 15-minute intervals to evaluate the restoration of healthy gait. Post-ACLR participants will perform an asymmetric walking intervention protocol session on two different days. On one day they will perform the protocol with a 0.25 m/s between-limb difference and on a separate day they will perform the protocol with a 0.50 m/s between limb difference. For the 0.25 m/s condition, one limb will be set to 1.0 m/s and the other 1.25 m/s (i.e., 1.0 m/s - 1.25 m/s). Similarly, for the 0.50 m/s condition, one limb will be set to 1.0 m/s and the other 1.50 m/s (i.e., 1.0 m/s - 1.50 m/s). Each participant will perform both the 0.25 m/s and 0.50 m/s protocols on separate days, and we will randomize who performs which protocol first or second. At least 3 weeks must pass between the two one-day sessions. Patient-specific simulations will be generated in OpenSim for each of the 40 post-ACLR individuals to assess differences in knee joint loading. Together with machine learning, these models will help evaluate the effectiveness of the asymmetric walking protocol in reducing detrimental knee loading. The study team hypothesizes that the 0.50 m/s perturbation will produce a larger reduction in between-limb asymmetry than the 0.25 m/s perturbation and reduce detrimental knee loading.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.25 m/s asymmetric session first | Active comparator | Other: Active Comparator: 0.25 m/s asymmetric session firstParticipants will perform three 15-minute sessions of walking with a 0.25 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.25 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s. |
| 0.50 m/s asymmetric walking session first | Active comparator | Other: Active Comparator: 0.50 m/s asymmetric session firstParticipants will perform three 15-minute sessions of walking with a 0.50 m/s asymmetric walking gait speed difference where one limb is set at 1.0 m/s and the other limb is set at 1.5 m/s. Each of these sessions will be followed by 5-minute de-adaptation sessions where they will perform a symmetric walking trial at 1.0 m/s. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able to read and speak English
- Age 18 - 30 years old
- Undergone ACLR surgery at the UConn Musculoskeletal Institute
- Must not have any concomitant surgeries or injuries
- Must be cleared to return-to-sport by a physician after they have completed rehabilitation
Key exclusion criteria (6 listed)
- Participants who have any recent inflammation, bleeding disorders, active bleeding, or infection within the lower limbs.
- History of injuries to their patellar tendon
- Cannot walk for extended periods of time
- Cannot have had any back and/or lower extremity injury that affects their ability to move.
- Cannot have difficulty or pain with walking, raising your arms, jogging, or jumping
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: 0.25 m/s asymmetric session firstParticipants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s. | Other | 0.25 m/s asymmetric session first |
| Active Comparator: 0.50 m/s asymmetric session firstParticipants will first perform an asymmetric walking trial where the between-limb gait speed difference is 0.50 m/s on day one. On the second day, participants will perform an asymmetric walking trial where the between-limb gait speed difference is 0.25 m/s. | Other | 0.50 m/s asymmetric walking session first |
Primary outcome
Change in Loading Rate
Time frame: Screening, Baseline, and Post-Treatment (immediately following the completion of the second session)
The rate at which the force is generated (Body Weight/sec). A decrease in loading rate would suggest that the participants adopted improved motor control while an increase would reflect impaired of motor control.
Change in Peak Vertical Ground Reaction Force
Time frame: Baseline, Post-Treatment (immediately following the completion of the second session)
The largest force (newtons) produced during stance. An increase in force would that the participants are not properly engaging their muscles to control their movement.
Change in Stride Time
Time frame: Baseline, Post-Treatment (immediately following the completion of the second session)
The time (seconds) measure from initial contact on the foot to the next initial contact on the same foot. A reduction in stride time would indicate that the participants are walking faster and more comfortable applying force to their limb during walking. An increase in walking speed, suggests that the participants are uncomfortable applying force to their limb.
Change in Knee Loading
Time frame: Baseline, Post-Treatment (immediately following the completion of the second session)
The forces (newtons) experienced at the knee. An increase in knee loading would indicate that they participants are unable to properly support their knee during walking, while a reduction in knee loads would indicate the participants are engaging the appropriate muscles to support their knee during walking.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Morgan, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: 0.25 m/s asymmetric session first and Active Comparator: 0.50 m/s asymmetric session first in people with Anterior Cruciate Ligament Reconstruction, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Morgan, PhD (860-486-8118, kristin.2.morgan@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Loading Rate (time frame: Screening, Baseline, and Post-Treatment (immediately following the completion of the second session)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.